For Immediate Release:
June 03, 2019

The FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP / VABP) in patients 18 years and older. The FDA successfully approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.

"A key global challenge we face a public health agency is addressing the threat of antimicrobial-resistant infections," said FDA Senior Deputy Commissioner Amy Abernethy, MD, Ph.D., "Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections. that can result in death in some patients. New therapies to treat these infections are important to meet patient needs because of increasing antimicrobial resistance. That's why, among our other efforts to address antimicrobial resistance, we're focused on supporting the development of safe and effective new treatments to give patients more options to fight life-threatening infections. "

HABP / VABP occurs in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to data from the U.S. Centers for Disease Control and Prevention, HABP and VABP are currently the second most common type of hospital-acquired infection in the United States, and are a significant outcome in patients in the intensive care unit (ICU).

The safety and efficacy of Zerbaxa for the treatment of HABP / VABP, administered via injection, was demonstrated in a multinational, double-blind study that compared Zerbaxa to another antibacterial drug in 726 adult patients hospitalized with HABP / VABP. The study showed that mortality and cure were similar between Zerbaxa and the comparator treatment.

The most common adverse reactions observed in the HABP / VABP trial among patients treated with Zerbaxa were elevated liver enzyme levels, renal impairment or failure, and diarrhea.
Zerbaxa should be used in patients with known hypersensitivity to components of Zerbaxa, as well as hypersensitivity to piperacillin / tazobactam or other members of the beta lactam class of antibacterial drugs.

Zerbaxa received FDA's Qualified Infectious Disease Product (QIDP) designation for the treatment of HABP / VABP. The QIDP designation is an anti-bacterial and antifungal drug product intended for serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of the QIDP designation, the Zerbaxa Marketing Application for the HABP / VABP has been granted Priority Review under which the FDA's goal is to take action on an application within an expedited time frame.

The FDA granted the Zerbaxa approval for the treatment of HABP / VABP to Merck & Co., Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public by the safety, effectiveness, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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